Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:33 PM
Study NCT ID:
NCT07232667
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Digital Technology for Active and Healthy Ageing in Taiwan
Sponsor:
China Medical University Hospital
Organization:
Study Overview
Official Title:
Healthy Taiwan Cultivation Plan: Building an Active-ageing Lifestyle in Rural Taiwan Through Integrating Novel Healthcare Technology - From Mitigating Digital and Health Literacy Gap, Establishing a Mobile Interactive Pro-active-ageing Information Platform, to Exploring Multi-dimensional Digital Biomarkers of Ageing
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Taiwan is entering a super-aged society in 2025, with more than 20% of the population aged 65 years or older. This rapid demographic shift, combined with increasing rates of chronic diseases, frailty, and dementia, has created growing challenges for healthcare and caregiving systems. Yunlin County, particularly its coastal region, has been one of Taiwan's earliest super-aged areas, showing higher rates of diabetes (10.5%), hypertension (28%), hyperlipidemia (26%), dementia (8%), and depression (12%) compared with national averages. Lifestyle factors such as tobacco (30%), betel nut (8%), and alcohol (15%) use are also more prevalent among local residents.
From 2022 to 2024, health screenings at CMU Beigang Hospital revealed a 36.1% abnormality rate among 12,222 visits, while another 5,965 assessments from the county's ICOPE program showed similarly high rates. Many older adults, particularly retired agricultural and fishing workers, experience sedentary lifestyles and polypharmacy-related risks, which worsen frailty, insomnia, depression, and cognitive decline. Low general and digital health literacy further limits their ability to adopt preventive behaviors, forming a vicious cycle between poor health and aging.
To address these challenges, the Ministry of Health and Welfare launched the "Healthy Taiwan Cultivation Plan." In alignment with this initiative, this project-led by CMU Beigang Hospital in collaboration with the National Health Research Institutes-aims to develop a wearable- and mobile-based health promotion model for rural older adults. The study will integrate research-grade actigraphy (Geneactiv), a mobile health platform ("iMED"), and the in-bed sensor iCue to monitor behavior, promote active aging, and enhance health and digital literacy. Ultimately, this project seeks to establish Taiwan's first integrated digital aging database and identify digital biomarkers for predicting cognitive and functional decline in older adults.
From 2022 to 2024, health screenings at CMU Beigang Hospital revealed a 36.1% abnormality rate among 12,222 visits, while another 5,965 assessments from the county's ICOPE program showed similarly high rates. Many older adults, particularly retired agricultural and fishing workers, experience sedentary lifestyles and polypharmacy-related risks, which worsen frailty, insomnia, depression, and cognitive decline. Low general and digital health literacy further limits their ability to adopt preventive behaviors, forming a vicious cycle between poor health and aging.
To address these challenges, the Ministry of Health and Welfare launched the "Healthy Taiwan Cultivation Plan." In alignment with this initiative, this project-led by CMU Beigang Hospital in collaboration with the National Health Research Institutes-aims to develop a wearable- and mobile-based health promotion model for rural older adults. The study will integrate research-grade actigraphy (Geneactiv), a mobile health platform ("iMED"), and the in-bed sensor iCue to monitor behavior, promote active aging, and enhance health and digital literacy. Ultimately, this project seeks to establish Taiwan's first integrated digital aging database and identify digital biomarkers for predicting cognitive and functional decline in older adults.
Detailed Description:
This single-arm interventional study aims to develop a wearable and mobile health-based model to improve health and digital literacy among older adults living in rural Taiwan. The study focuses on Yunlin County, one of Taiwan's earliest super-aged regions, where chronic diseases, frailty, and dementia are highly prevalent. The project combines community-based interventions with continuous monitoring using wearable and digital tools to promote active aging and reduce health disparities.
The intervention integrates a research-grade wearable actigraphy device (Geneactiv), an AI-supported mobile health platform (iMED), and a smart in-bed sensor (iCue). These tools will continuously monitor physical activity, sleep patterns, and physiological parameters, while also providing real-time feedback and personalized health education. In addition, the "Aging Well Taiwan" program and the World Health Organization's Integrated Care for Older People (ICOPE) framework will be used to strengthen both health literacy and digital literacy among participants.
Phase I (2025-2026):
The first phase will establish baseline data and evaluate the feasibility, usability, and acceptability of wearable and mobile tools in community settings. Participants will wear Geneactiv devices for at least two weeks, complete ICOPE assessments, and provide blood samples for dementia-related biomarkers such as phosphorylated Tau 217 (pT217) and Neurofilament Light Chain (NfL). Validated questionnaires will be used to assess health literacy, digital literacy, and lifestyle factors.
Phase II (2027-2029):
The second phase will implement a single-arm intervention integrating the mobile health platform with wearable and sensor data. Participants will be followed up every three months to track changes in activity, sleep, medication use, mental well-being, and behavioral outcomes. Quantitative data will be analyzed using GGIR, R, and SPSS software, while qualitative interviews will explore usability, user satisfaction, and behavioral changes related to technology use.
This study will establish Taiwan's first integrated digital aging database that merges wearable, behavioral, and biological data. Through collaboration with international partners such as the RADAR-AD consortium, the project aims to identify digital phenotypes and biomarkers associated with cognitive and functional decline. Ultimately, the study aims to establish a sustainable, evidence-based, and technology-supported model that promotes healthy aging and improves well-being among older adults in rural communities.
The intervention integrates a research-grade wearable actigraphy device (Geneactiv), an AI-supported mobile health platform (iMED), and a smart in-bed sensor (iCue). These tools will continuously monitor physical activity, sleep patterns, and physiological parameters, while also providing real-time feedback and personalized health education. In addition, the "Aging Well Taiwan" program and the World Health Organization's Integrated Care for Older People (ICOPE) framework will be used to strengthen both health literacy and digital literacy among participants.
Phase I (2025-2026):
The first phase will establish baseline data and evaluate the feasibility, usability, and acceptability of wearable and mobile tools in community settings. Participants will wear Geneactiv devices for at least two weeks, complete ICOPE assessments, and provide blood samples for dementia-related biomarkers such as phosphorylated Tau 217 (pT217) and Neurofilament Light Chain (NfL). Validated questionnaires will be used to assess health literacy, digital literacy, and lifestyle factors.
Phase II (2027-2029):
The second phase will implement a single-arm intervention integrating the mobile health platform with wearable and sensor data. Participants will be followed up every three months to track changes in activity, sleep, medication use, mental well-being, and behavioral outcomes. Quantitative data will be analyzed using GGIR, R, and SPSS software, while qualitative interviews will explore usability, user satisfaction, and behavioral changes related to technology use.
This study will establish Taiwan's first integrated digital aging database that merges wearable, behavioral, and biological data. Through collaboration with international partners such as the RADAR-AD consortium, the project aims to identify digital phenotypes and biomarkers associated with cognitive and functional decline. Ultimately, the study aims to establish a sustainable, evidence-based, and technology-supported model that promotes healthy aging and improves well-being among older adults in rural communities.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: